Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-704-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1955
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles. For some data limited details were available, however the study is relevant, adequate and reliable for classification.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 955
- Report date:
- 1955
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 7 days observation instead of 14 days
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
- EC Number:
- 939-704-6
- Cas Number:
- 867040-07-1
- Molecular formula:
- Molecular formula cannot be given as the substance is a mixture
- IUPAC Name:
- Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: By groups
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not provided
ENVIRONMENTAL CONDITIONS: Not provided
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 10.0, 14.7, 21.5 and 31.6 mL/kg bw . The material as received was reported to contain 35% active ingredient.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:7 days
- Frequency of observations and weighing: Not provided
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs - Statistics:
- Thompson moving average method
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 18.7 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: confidence limits from 13.7 to 25.6 mL/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 6.6 mL/kg bw
- Based on:
- act. ingr.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 6 500 mg/kg bw
- Based on:
- other: solids content
- Remarks on result:
- other: confidence limits from 4.8-9.0 g/kg bw
- Mortality:
- In the 1.0 mL/kg bw dose group 1/5 animals died, in the 14.7 mL/kg dose group 1/5 animals died, in the 21.5 mL/kg dose group 3/5 animals died and in the 31.6 mL/kg dose group 5/5 animals died.
- Clinical signs:
- other: Following oral administration of [Trade name], the rats at all dosage levels appeared depressed and exhibited labored respiration and a watery diarrhea. The surviving animals continued to exhibit these signs for 24 or 48 hours following oral administratio
- Gross pathology:
- Gross autopsies performed upon the animals that died showed the following significant gross pathology: hyperemic lungs, irritation of the gastrointestinal tract, and congested kidneys and adrenals. Gross autopsies performed upon the surviving animals at the end of the observation period showed no significant pathology.
- Other findings:
- Not provided
Any other information on results incl. tables
Table 1. Acute toxicity of [Trade name] following oral administration of the undiluted material to male albino rats. Values are number of animals dead/number of animals tested, cumulative.
Dose (mL/kg) |
Time of death (days) |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
10.0 |
0/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
14.7 |
0/5 |
0/5 |
0/5 |
1/5 |
1/5 |
1/5 |
1/5 |
21.5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
31.6 |
3/5 |
4/5 |
4/5 |
5/5 |
|
|
|
LD50 (mL/kg) = 18.7
Confidence limits (mL/kg) = 13.7-25.6
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is considered to be a practically non-toxic material by ingestion in single doses. The acute LD50 of undiluted test item for male albino rats, calculated by the Thompson moving average method, is 18.7 mL/kg of body weight, with confidence limits from 13.7 to 25.6 mL/kg. Based on a concentration of 35% active ingredient, the acute oral LD50 would be approximately 6.6 mL/kg, corresponding to ca. 6500 mg act.ingr./kg bw.
- Executive summary:
Groups of five male albino rats each were administered orally by stomach tube the undiluted test item containing 35.8% active ingredient at dosage levels of 10.0, 14.7, 21.5, or 31.6 mL/kg of body weight. Rats at all dosage levels appeared depressed and exhibited labored respiration and a watery diarrhea. The surviving animals continued to exhibit these signs for 24 or 48 hours following oral administration. Thereafter, the survivors at the two lower dosage levels appeared normal, while those at the 21.5 m L/kg level appeared slightly depressed through the fifth day following dosage.
Gross autopsies performed upon the animals that died showed hyperemic lungs, irritation of the gastrointestinal tract, and congested kidneys and adrenals. Surviving animals at the end of the observation period showed no significant pathology.
The acute LD50 of undiluted test item for male albino rats was ca. 6500 mg act.ingr./kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.